Instituto Nacional de Saúde (INS), Maputo Province, Mozambique.
Centre for International Health (CIH), University of Munich (LMU), Munich, Germany.
PLoS One. 2021 Dec 2;16(12):e0260126. doi: 10.1371/journal.pone.0260126. eCollection 2021.
Vaccine efficacy testing requires engagement of willing volunteers with high disease incidence. We evaluated factors associated with willingness to participate in potential future HIV vaccine trials in Maputo, Mozambique.
Adults aged 18-35 years without HIV and who reported at least two sexual partners in the 3 months prior to screening were enrolled into a 24-month observational study. They were asked at screening and exit if they would be willing to participate in a theoretical HIV vaccine study. Bivariate and multivariate logistic regression analyses were done between willingness to participate, demographic, sexual behavior, and motivational factors for screening visit data. Logistic regression with generalized estimating equations (GEE) was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for factors potentially associated with willingness to participate for data from both visits.
A total of 577 participants without HIV were eligible, including 275 (48%) women. The mean age was 22.2 (SD ± 3.9) years. At screening 529 (92%) expressed willingness to participate and the proportion remained stable at 378 (88%) of the 430 participants retained through the exit visit (p = 0.209). Helping the country (n = 556) and fear of needles (n = 26) were the top motive and barrier for willingness to participate, respectively. Results from the GEE binary logistic regression (screening visit and exit visit) showed that wanting to learn how to avoid risk behaviors (aOR 3.33, 95% CI: 1.61-6.86) and feeling protected against HIV infection (aOR 2.24, 95% CI: 1.07-4.7) were associated with willingness to participate in HIV vaccine studies.
The majority of our study population in Mozambique expressed willingness to participate in a theoretical HIV vaccine trial. Participation in a HIV vaccine trial was seen as a way to contribute to the fight against HIV but was associated with some unrealistic expectations such as protection against HIV. This reinforces the need for continuous mobilization and awareness of potential participants to HIV vaccine trial.
疫苗效力测试需要招募愿意参与的志愿者，且这些志愿者所在地区的疾病发病率较高。我们评估了在莫桑比克马普托影响人们参与潜在未来 HIV 疫苗试验意愿的相关因素。
在筛选前 3 个月内报告至少有 2 个性伴侣的 18-35 岁成年人被纳入一项为期 24 个月的观察性研究。在筛选和退出时，他们被问及是否愿意参与一项理论上的 HIV 疫苗研究。对筛选就诊数据中的参与意愿、人口统计学、性行为和动机因素进行了单变量和多变量逻辑回归分析。使用广义估计方程（GEE）对来自两次就诊的数据进行逻辑回归，以估计与参与意愿相关的因素的比值比（OR）和 95%置信区间（CI）。
共有 577 名无 HIV 的参与者符合条件，包括 275 名（48%）女性。平均年龄为 22.2（SD ± 3.9）岁。在筛选时，529 名（92%）表达了参与意愿，而在 430 名保留至退出就诊的参与者中，有 378 名（88%）的比例保持稳定（p = 0.209）。帮助国家（n = 556）和害怕针头（n = 26）是表达参与意愿的主要动机和障碍。来自 GEE 二项逻辑回归的结果（筛选就诊和退出就诊）表明，希望学习如何避免风险行为（aOR 3.33，95%CI：1.61-6.86）和感到免受 HIV 感染的保护（aOR 2.24，95%CI：1.07-4.7）与参与 HIV 疫苗研究的意愿相关。
我们在莫桑比克的研究人群中，大多数人表示愿意参与理论上的 HIV 疫苗试验。参与 HIV 疫苗试验被视为对抗 HIV 的一种方式，但也与一些不切实际的期望有关，例如对 HIV 的保护。这再次强调了需要持续动员和提高潜在参与者对 HIV 疫苗试验的认识。
